Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group II and 177Lu-DOTATOC in the reply filed on 4/14/2026 is acknowledged. Claims 1-46 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I, and there being no allowable generic or linking claim.
Status of Claims
Withdrawn: 1-46
Examined Herein: 47-56
Claim Objections
Claims 48-51 and 53-56 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). Accordingly, claims 48-51 and 53-56 have not been further treated on the merits.
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PCT/EP2020/081143 on 11/5/2020 and PCT/EP2021/080822 on 11/5/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/5/2023, 7/25/2023, 8/9/2023, 11/10/2023, 4/10/2024, 4/16/2024, and 9/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 5/5/2023 are accepted.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 47 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Jain (US 2022/0040335 A1, Filed 9/11/2019), in view of Yang (US 2007/0122342 A1, Published 5/31/2007).
With respect to claim 47, Jain discloses a method for treating cancer in a subject in need thereof comprising administering:
(a) a radiolabeled complex, 99mTc-EC, comprising (i) a radionuclide, 99mTc, and (ii) a chelating agent, ethylenedicysteine (EC); and
(b) para-aminohippuric acid (PAH). [Jain, 0009, 0010, 0042 0049, 0058, 0062]
With respect to claim 52, Jain discloses a combination therapy comprising:
(a) a radiolabeled complex, 99mTc-EC, comprising (i) a radionuclide, 99mTc, and (ii) a chelating agent, ethylenedicysteine (EC); and
(b) para-aminohippuric acid (PAH). [Jain, 0009, 0010, 0042 0049, 0058, 0062]
Jain does not disclose the chelating agent is linked to a targeting molecule.
However, with respect to claim 47, Yang discloses a method for treating cancer (i.e. folate-positive cancer or estrogen-positive cancer) in a subject in need thereof comprising administering to the subject:
a radiolabeled complex, 99mTc-EC-anticancer agent, comprising (i) a radionuclide, 99mTc, and (ii) an anticancer targeting molecule (i.e. folate) linked to a chelating agent, ethylenedicysteine (EC). [Yang, 0012-0021]
With respect to claim 52, Yang discloses a combination therapy comprising administering:
a radiolabeled complex, 99mTc-EC-anticancer agent, comprising (i) a radionuclide, 99mTc, and (ii) an anticancer targeting molecule (i.e. folate) linked to a chelating agent, ethylenedicysteine (EC). [Yang, 0012-0021]
Modifying the method and combination therapy disclosed by Jain by conjugating an anticancer targeting molecule (i.e. folate) to the radiolabeled complex, results in the method of claim 47 and 52.
It would be obvious to one of ordinary skill in the art to modify the method and combination therapy disclosed by Jain by conjugating an anticancer targeting molecule (i.e. folate) to the radiolabeled complex, 99mTc-EC, and have a reasonable expectation of success. Jain discloses methods for treating cancer in a subject comprising administering a tracer/radiolabeled complex, 99mTc-EC. Yang discloses methods for treating cancer in a subject comprising administering a tracer/radiolabeled complex, 99mTc-EC-anticancer agent, wherein an anticancer targeting molecule (i.e. folate) is linked to the chelating agent, EC. Yang establishes that an anticancer agent may be conjugated to the chelating agent of 99mTc-EC. Accordingly, the combined teachings of Jain and Yang suggest an anticancer agent may be conjugated to the chelating agent of the tracer/radiolabeled complex, 99mTc-EC, disclosed by Jain. Therefore, it is reasonable to expect the method and combination therapy disclosed by Jain may be modified by conjugating an anticancer targeting molecule (i.e. folate) to 99mTc-EC. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II). In the present case, Yang discloses the radiolabeled complex, 99mTc-EC, is used to deliver the anticancer agent to a specific cancer lesion in the body. [Yang, 0015] Therefore, one would have been motivated by the expectation that conjugating an anticancer agent to 99mTc-EC would enable 99mTc-EC to deliver the anticancer agent to a specific cancer lesion in the body.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 47 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31, 34-41, and 43-45 of copending Application No. 17/608,921 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to treatment methods wherein PAH and a radiolabeled complex containing a chelate or salt or carboxylic acid derivative thereof is administered to a subject. Thus, the inventions disclose overlapping subject matter as the limitations of the pending claims are disclosed in the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights